Lifestyle Intervention for Patients With Impaired Glucose Regulation

Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation

Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Low fat diet intensive intervention; Other: Low-Carbon Water Diet Intensive Intervention

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Cixi, Zhejiang, China, 315300
      • Cixi People's Hospital
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital of Zhejiang University School of Medicine
    • Jinhua, Zhejiang, China, 321000
      • Jinhua municipal central hospital
    • Lishui, Zhejiang, China, 323020
      • Lishui People's Hospital
    • Ningbo, Zhejiang, China, 315010
      • Ningbo Huamei Hospital, University of Chinese Academy of Sciences
    • Shaoxing, Zhejiang, China, 312000
      • Shaoxing People's Hospital
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University
    • Yuyao, Zhejiang, China, 315400
      • Yuyao People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL)

  • 24 kg/m2 ≤ BMI ≤ 35 kg/m2

    • Those who are willing to accept assessment and sign informed consent.

Exclusion Criteria:

• Patients diagnosed with diabetes or undergoing diabetes treatment;

  • Receiving drugs or surgery for weight loss at present or in the past 3 months;

    • Receiving corticosteroid or thyroid hormone treatment;

      • Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases;

        • Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake;

          • Diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ Suffering from infectious diseases such as active tuberculosis and AIDS; ⑨ During pregnancy or lactation; ⑩Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group1; Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc.
Experimental: Group2; In addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients	Dietary supplement: Low fat diet intensive intervention; education and Compound protein solid beverage
Experimental: Group3; In addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients	Other: Low-Carbon Water Diet Intensive Intervention; education and Nutrition bar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting blood glucose	ten weeks
Blood glucose 2 hours after meal	ten weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pianhong Zhang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: July 12, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 2019-317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No